Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Reintroduction of SALSA Revives Labs’ Hopes for PAMA Relief
New legislation would force CMS to change the way it calculates Medicare prices for lab tests.
FTC Orders Illumina to Unwind Grail Acquisition
On Friday, the US federal trade commission ordered Illumina to divest Grail, which it acquired for $8 billion in August 2021.
Texas Lab Settles Kickback Allegations for $5.9M
Last week saw three key settlements, including a lab accused of paying kickbacks for test referrals and billing for unnecessary drug tests.
DOJ Increases FCA Penalties
The U.S. Department of Justice recently announced inflationary increases to civil monetary penalties under the False Claims Act.
OTC COVID-19/Influenza Test Approval Comes Too Late to Save Lucira Health
No company better embodies the vicissitudes of running a COVID-19-focused diagnostics business during the pandemic period than Lucira Health.
FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Lab Companies Turn to Product Integrations to Cut Costs, Risks, & Time
Product integration collaborations have become increasingly common, with five such deals being announced between February and mid-March.
Med-Tech Startups Survive SVB Collapse but Face New Concerns
While only time will tell how bad the ultimate damage turns out to be, it appears for now at least that the industry has dodged a bullet.
Illumina Faces Proxy Battle Over Grail Acquisition
Carl Icahn has decided to take his beef with Illumina’s board of directors over the acquisition directly to company shareholders.
Medicare Pay Rates Are Adequate without Major Hikes, MedPAC Says
Agency’s annual report to Congress concludes that providers are doing just fine and don’t need a big bump in pay at this time.
